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The study was withdrawn prior to IRB approval and prior to enrollment. The study was never opened, and no participants were enrolled.
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The primary objective of this study is to evaluate the efficacy and safety tamsulosin in reducing stent discomfort in the pediatric population in the peri-operative period. The secondary objective is to compare the efficacy of tamsulosin with that of oxybutynin in reducing stent discomfort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxybutynin group | Active Comparator | This group will be prescribed oxybutynin as well as standard narcotic pain medications. Oxybutynin will be prescribed based off of standard dosing. Patients who are unable to swallow pills will be given oxybutynin elixir (0.5mg/kg/day, divided TID). Patients who are able to swallow pills will be given oxybutynin 5mg either BID or TID. |
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| Tamsulosin group | Active Comparator | This group will be prescribed tamsulosin and standard narcotic pain medication. Patients will be given tamsulosin 0.4mg at bedtime. This dosage has been used in other studies for children age ≥ 4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug |
| ||
| Oxybutynin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of doses of pain in medication used | After surgery, each child will be prescribed the standard dosage of oxycodone/acetaminophen based on their weight. We will have the patient's family record the number of doses of narcotics used from post-operative day #1 to post-operative day #5 to assess their pain needs. | 5 days post-op |
| Pain scale based on the faces pain score | We will have the family members record the child's pain score in the morning and evening using the faces pain scale and record the score. | 5 days post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| C005419 | oxybutynin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |